Bone grafting material, method and implant

a bone grafting and bone technology, applied in the field of bone grafting materials, can solve the problems of troublesome procedures, additional pain for patients, and undamaged bone tissue must be taken up from an unspoiled portion, so as to enhance bone formation and accelerate the formation of new bone or cartilage tissue, the effect of reducing the risk of side effects

Inactive Publication Date: 2007-03-13
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0016]An advantage of the invention is that the administration of pyrrolidone enhances and accelerates the formation of new bone or cartilage tissue.
[0017]In one embodiment of the invention, the bone grafting material comprises at least one bone morphogenetic protein (BMP). An advantage of the embodiment is that the administration of BMPs in combination with a pyrrolidone enhances bone formation in a synergistic manner. This affords advantages in terms of smaller amounts of the material needed for the desired effect, which is of great importance in view of the laborious production of especially recombinant BMPs (rBMPs) in particular. Also, the risk of side effects decreases significantly when smaller amounts of foreign material can be used.
[0018]In another embodiment of the bone grafting material of the invention, the porous carrier is of calcium phosphate ceramics (CPCs), such as hydroxyapatite (HA), β-tricalcium phosphate (β-TCP) and Brushite.
[0019]In another embodiment of the bone grafting material of the invention, the porous scaffold is manufactured by sintering bioactive glass fibers which is further immersed into a simulated body fluid (SBF) in order to create a carrier of CaP and a Si-rich layer on the glass surface. The pyrrolidone is applied to the CaP—Si-layer prior to implanting the material into a bone defect.
[0020]In one embodiment of the method of the invention of producing a bone grafting material an anorganic mineral bone matrix of bovine origin is loaded with pyrrolidone prior to implantation.
[0021]In one embodiment of the implant of the invention, the material of the implant is a biopolymer-bioceramic composite that is processed by extrusion, injection molding or an other manufacturing method, and prior to manufacturing the composite, the porous bioceramic is loaded with pyrrolidone.

Problems solved by technology

However, to perform such an operation, normal, undamaged bone tissue must be taken up from an unspoiled portion.
This operation causes additional pain to the patient and is, in addition, a very troublesome procedure.
Moreover, when the volume of the defect or void in the patient's bone is large, the amount of bone obtainable from the patient's own body is not always adequate to fully fill in the defect or void.
For these reasons, post-operation recovery of the defect is not always satisfactory.
Accordingly, such an operation has not yet been recognized as fully satisfactory in practice.
However, it has been recognized that these materials tend to dissolve or otherwise deteriorate in the environment of living tissue and that these materials are toxic to the living body and cause a so called foreign body rejection reaction.
However, the conventional ceramic materials have a disadvantage in that the bone formation activity or bone filling process is relatively slow.
However, due to the instant degradation of the BMPs upon contact with body fluids and the strong morphogenetic action of the BMPs, un-physiologically high doses of the BMPs are needed for the osteoinductive bioactivity [Weber, F. E., et al., Int J Oral Maxillofac Surg 31 (2002) 60 to 65; Rose, F. R. A. and Oreffo, R. O. C. Biochem Biophys Res Corn 292 (2002) 1 to 7].
Topical administration routes must be used, which makes the choice of the carrier system critical, and no suitable carrier systems are currently available.
Since the BMPs are usually produced with recombinant techniques and thus are expensive and available only in limited amounts, the BMPs, despite the acknowledged effect, have had no impact on the medical treatment of patients and they are not clinically applied at present.

Method used

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  • Bone grafting material, method and implant

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0030]Two batches of bioactive glasses with compositions shown in Table 1 were first formed by melting the raw-materials in Pt-Au crucible for 2 to 3 hours at approximately 1360° C.

[0031]

TABLE 1The composition of the bioactive glasses [wt-%].GlassNa2OK2OMgOCaOB2O3P2O5SiO2A18 90141454B12155111254

[0032]From both batches of the bioactive glasses, fibers with a diameter of approximately 75 μm were then formed by melt spinning. The fibers were further cut to have a segment length of approximately 3 mm. From the obtained fibre segments were formed 3-dimensional scaffolds with open network. The forming took place by first placing the fibre segments in a mould and then sintering the fibers at elevated temperatures.

[0033]The obtained scaffolds were then immersed into a simulated body fluid for a one-week period in order to obtain a formation of Si-rich layer and calcium phosphate (CaP) precipitation on the surface of the scaffolds. Scaffolds containing a CaP surface as a carrier layer were t...

example 2

[0048]Six pieces of bone grafting material comprising a porous bioactive glass scaffold “A” or “B” (the compositions being the same as in Example 1) and with a CaP layer on top of the glass surface were manufactured as described in example 1. All the samples were weighed with a top balance and the samples were then placed into a high-pressure chamber (with a total volume of 0.37 dl) together with 2 ml of NMP. The samples were placed on a metallic sample holder. The high-pressure chamber was closed and the chamber was first filled with a CO2 vapor at room temperature. The chamber was then heated to a temperature of 60° C. so that the pressure inside the chamber increased up to 120 bar. These conditions were remained for 24 hours, and the pressure was lowered slowly within 15 minutes to reach a normal air pressure. The weight of the samples was then measured.

[0049]

TABLE 3The amount of NMP in scaffold / carrier structures.Weight afterSample No.Initial weight [g]treatment [g]Weight-% of N...

example 3

[0050]Various bioceramics and one bioceramic composite were acquired, namely[0051]1) Synthetic calcium phosphate (CaP), 3-dimensional scaffold manufactured by sintering CaP powder,[0052]2) Bio-Oss®, an anorganic mineral bone matrix of bovine origin, and[0053]3) Hydroxyapatite (HA) powder with a particle size of 4 μm.

[0054]The samples were dried in a vacuum and further placed in a chamber containing 1-methyl-2-pyrrolidone (NMP) as described in Example 1. The masses of the samples were monitored prior to placing them in a chamber and 5 and 7 days after the placement in the chamber. The amount of absorbed NMP as weight-% is shown in Table 4.

[0055]

TABLE 4The absorption of NMP.NMP in structureNMP in structureafter 5 daysafter 7 daysSample No.[wt-%][wt-%]10.691.06232.2439.2030.160.23

[0056]Table 4 shows that the absorbtion of NMP varies significantly depending on the composition and structure of the bioceramic material. The highest amount of NMP was absorbed by Bio-Oss, approximately 40 wt...

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Abstract

A bone grafting material, a method of producing the same, and an implant. The bone grafting material comprises a porous carrier of ceramic or glass ceramic or glass material and at least one pyrrolidone arranged in the carrier.

Description

JOINT RESEARCH AGREEMENT[0001]The invention claimed herein was made by or on behalf of Inion, Ltd. and the University of Zurich who are parties to a joint research agreement. The agreement was executed by the University of Zurich on Feb. 1, 2003 and by Inion on Feb. 17, 2003. The agreement came into effect on Feb. 17, 2003, before the date the claimed invention was made. The agreement concerns the field of bioactive materials for bone formation, and the claimed invention was made as a result of activities undertaken within the scope of the agreement.FIELD OF THE INVENTION[0002]The present invention relates to a bone grafting material comprising a porous carrier of ceramic or glass ceramic or glass material.[0003]The present invention further relates to a method of producing a bone grafting material.[0004]The present invention further relates to an implant comprising a porous ceramic or glass ceramic or glass material.BACKGROUND OF THE INVENTION[0005]In surgical and orthopedic treatm...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): A61F2/28A61K31/40A61F2/00A61K31/4015A61K45/00A61L27/10A61L27/40A61L27/54
CPCA61L27/10A61L27/427A61L27/56A61L27/54A61L2430/02A61L2300/414A61F2/00A61L27/00A61L27/40
Inventor PIRHONEN, EIJAMOIMAS, LOREDANAWEBER, FRANZ
Owner INION
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